MAUDE Adverse Event Report: LIMACORPORATE S.P.A. REVERSE ADAPTOR SLEEVE

Model Number 9013.52.141

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/05/2018

Event Type  malfunction  

Manufacturer Narrative

The check of the manufacturing charts of the lot # involved (#2015aa093) did not show any anomaly on the 35 smr adaptor sleves manufactured with this lot #.No other complaints reported on the same lot#.We will submit a final mdr once the investigation will be completed.

Event Description

During a shoulder surgery, metal prong of smr reverse adaptor sleeve - model # 901352141, lot# 15aa093 broke off.Even if the instrument broke, surgeon was able to use it to successfully, concluding the surgery without negative effects on patient.Estimated number of uses of the instrument is unknown.Event happened in (b)(6) on (b)(6) 2018.

Event Description

During shoulder surgery performed on (b)(6) 2018, one of the metal pegs of the smr reverse adaptor sleeve (code 9013.52.141, lot# 15aa093) broke off.According to the info reported, damage was noticed once the surgeon had already finished using the instrument (surgery already successfully completed).No adverse effect for the patient due to this issue.Estimated number of uses of the instrument is unknown.Event happened in australia.

Manufacturer Narrative

Dhr check: the check of the manufacturing charts and raw material certificate of the lot # involved (2015aa093), did not show any anomaly on the 35 smr adaptor sleeves manufactured with this lot #.No other complaints received on the same lot#.Instrument analysis: limacorporate received the involved instrument for analysis.We did not receive the broken peg together with the instrument body.By a visual analysis, we could confirm that one of the 4 teeth of the instrument broke off at the base of the tooth.The remaining 3 teeth of the extractor were intact.A rockwell hardness test (astm e18-19) was performed on the surface of the instrument to confirm the conformity of the material (aisi 630).The test results showed a value of 41hrc, in compliance with recommended value by astm a564 (minimum allowed: 40 hrc).The instrument has been manufactured in 2015, the breakage occurred in march 2018.The number of uses is not known.Conclusion: no definitive conclusion can be drawn on the causes of the breakage of the instrument peg.Manufacturing records were checked and the batch was manufactured correctly up to specs and in-line with the relevant checks and tests and no manufacturing deviations were reported.Based on the info provided and according to our analysis, we can only speculate that the breakage could have been related to an intensive/unintended use of the instrument.Its repeated use during surgeries could have in fact caused slight and repeated bending of the peg over time that eventually lead to the breakage of the metal tooth.Pms data: according to our pms data, this is the first and only case of breakage of the metal tooth involving instruments with code (b)(4).We only received another complaint about bending of the metal peg, but no breakage reported.A total of (b)(4) pieces have been manufactured with code (b)(4).We can therefore estimate that the specific breakage rate of the instrument peg is 0.179% (ww).No specific corrective action for this case.Limacorporate will continue monitoring the market to promptly detect any future similar issue.

• Brand Name: REVERSE ADAPTOR SLEEVE
• Type of Device: REVERSE ADAPTOR SLEEVE
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale,52; via nazionale 52; villanova di san daniele, 33038 ; IT 33038
• MDR Report Key: 7442695
• MDR Text Key: 106265255
• Report Number: 3008021110-2018-00021
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: K100858
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9013.52.141
• Device Lot Number: 2015AA093
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1